clopidogrel bisulfate

Product NDC: 43353-269
11-digit product format: 433530269
Labeler code: 43353
Product ID: 43353-269_0cf628ea-f6b0-4e31-8640-d40b7aa64826
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clopidogrel bisulfate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA076274
Marketing category: ANDA
Marketing start: 2012-05-17
Marketing end: 0000-00-00
Substance: CLOPIDOGREL BISULFATE
Active strength: 75 mg/1
Pharmacologic classes: Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
39fa80eb-1490-ce82-3d3a-820ae7c37b85	Product name	5	20250618

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43353-269-30	2020-01-31	C162847	48780-1	9d75b9d0-e4d0-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997
43353-269-60	2020-01-31	C162847	48780-1	9d75b9d0-e4d0-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely and effectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral use Initial U.S. Approval: 1997

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43353-269-30	clopidogrel bisulfate	30 in 1 BOTTLE	TABLET, FILM COATED	30		3
43353-269-60	clopidogrel bisulfate	90 in 1 BOTTLE	TABLET, FILM COATED	90		3

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-269-30	EA - Each	43353-269	05edfffd-0a62-4492-bd5c-0e9b0037ca35	1	2017-11-06
43353-269-60	EA - Each	43353-269	588df737-cda9-4e51-8043-92ec084d9d20	1	2017-11-06

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-269	CLOPIDOGREL BISULFATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3	Legacy NDC, 2 package rows	20171021_9036093d-8957-472d-916b-1425d38da373.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
08I79HTP27	CLOPIDOGREL BISULFATE	120202-66-6	CLOPIDOGREL BISULFATE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309362	clopidogrel 75 MG Oral Tablet	PSN	9036093d-8957-472d-916b-1425d38da373	3
309362	clopidogrel 75 MG Oral Tablet	SCD	9036093d-8957-472d-916b-1425d38da373	3
309362	clopidogrel 75 MG (as clopidogrel bisulfate 97.875 MG) Oral Tablet	SY	9036093d-8957-472d-916b-1425d38da373	3

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
43353-269-30	43353026930	30 in 1 BOTTLE	Historical
43353-269-60	43353026960	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
clopidogrel bisulfate	Aphena Pharma Solutions - Tennessee, LLC	2017-10-17	HUMAN PRESCRIPTION DRUG LABEL	3